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    Pharmaceuticals and Medical Devices Agency

    Japan's regulatory authority for medical devices, drugs, and regenerative medicine.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    PMDA conducts scientific reviews of marketing authorization applications and post-marketing safety for drugs and medical devices in Japan, working under the Ministry of Health, Labour and Welfare (MHLW).

    What this means in practice

    Japan classifies devices into Classes I–IV. Higher-risk devices require Shonin approval; many Class II devices use third-party Ninsho certification. PMDA accepts MDSAP audits in lieu of QMS inspections for many manufacturers.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    PMDA·1IMDRF·1RAPS·1
    1. 1
      PMDA English site
      Verified
      PMDApmda.go.jp
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.